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Non‐Biological Complex Drugs


Follow-on versions of glatiramer acetate in Russia and Europe posted 24/02/2017

US generics company Alvogen announced in September 2016 that it had launched a follow-on version of glatiramer acetate in Cen...


Follow-on intravenous iron formulations in haemodialysis patients posted 11/02/2017

A study into the efficiency of follow-on intravenous (IV) iron formulations compared to originator formulations in haemodialy...


US guidelines for follow-on NBCDs posted 29/07/2016

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Polices & Legislation

FDA to set up abbreviated pathway for complex products posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and...


Challenges in the assessment of ophthalmic emulsions posted 18/11/2016

Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs)...

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